Just as you read the insert of a prescribed prescription drug for side effects and/or warnings so you have true informed consent you should do the same for the va((ines you are being asked to insert into yourself and your children.
All links are directed to the FDA site so you can see for yourself.
True informed consent is being
VA((INES' PACKAGE INSERTS: SECTION 13
NO va((ine has been evaluated for the potential to:
Cause Cancer
Mutate DNA
Impair Fertility of Both Males and Females
SAMPLE VACCINE INSERT SECTION: Section 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility VAXCHORA has not been evaluated for the potential to cause carcinogenicity or genotoxicity, or to impair fertility.
SOURCE: U.S. FOOD AND DRUG ADMINISTRATION (FDA) http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm093833.htm
NOTES:
CHECK BELOW FOR THE 83 VACCINE INSERTS INFORMATION - MOST OFTEN FOUND IN SECTION 13 (but not always):
Beware of "patients inserts" are sometimes not the same as "physicians inserts" and may not contain the same information.
Trade Name
1. Adenovirus Type 4 and Type 7 Vaccine, Live, Oral Section 13, omittted
No Trade Name
2. Anthrax Vaccine Adsorbed 13. NONCLINICAL TOXICOLOGY The effect of BioThrax on embryo-fetal and pre-weaning development was evaluated in a developmental toxicity study using pregnant rabbits. One group of rabbits was administered BioThrax twice prior to gestation and during the period of organogenesis (gestation day 7). A second group of rabbits was administered BioThrax twice prior to gestation and on gestation day 17. BioThrax was administered at 0.5 ml/rabbit/occasion, by intramuscular injection. No adverse effects on mating, fertility, pregnancy, parturition, lactation, embryo-fetal or preweaning development were observed. There were no vaccine-related fetal malformations or other evidence of teratogenesis noted in this study
Biothrax
3. BCG Live BCG VACCINE has not been evaluated for carcinogenic, mutagenic potentials or impairment of fertility.
BCG Vaccine
4. BCG Live TICE® BCG has not been evaluated for its carcinogenic, mutagenic potentials or impairment of fertility.
TICE BCG
5. Cholera Vaccine Live Oral VAXCHORA has not been evaluated for the potential to cause carcinogenicity or genotoxicity, or to impair fertility.
Vaxchora
6. Diphtheria & Tetanus Toxoids Adsorbed Diphtheria and Tetanus Toxoids Adsorbed has not been evaluated for carcinogenicity, mutagenic potential, or impairment of fertility.
No Trade Name
7. Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed Tripedia vaccine has not been evaluated for its carcinogenic or mutagenic potentials or impairment of fertility.
Tripedia
8. Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed INFANRIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
Infanrix
9. Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed DAPTACEL has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.
DAPTACEL
10. Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed, Hepatitis B (recombinant) and Inactivated Poliovirus Vaccine Combined PEDIARIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
Pediarix
11. Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine KINRIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
KINRIX
12. Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine Quadracel has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.
Quadracel
13. Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine Pentacel vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.
Pentacel
14. Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) Liquid PedvaxHIB has not been evaluated for carcinogenic or mutagenic potential, or potential to impair fertility.
PedvaxHIB
15. Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) ActHIB vaccine has not been evaluated for its carcinogenic or mutagenic potential or impairment of fertility.
ActHIB
16. Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) HIBERIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
Hiberix
17. Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) & Hepatitis B Vaccine (Recombinant) COMVAX has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.
Comvax
18. Hepatitis A Vaccine, Inactivated HAVRIX has not been evaluated for its carcinogenic potential, mutagenic potential, or potential for impairment of fertility.
Havrix
19. Hepatitis A Vaccine, Inactivated VAQTA has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.
VAQTA
20. Hepatitis A Inactivated and Hepatitis B (Recombinant) Vaccine TWINRIX has not been evaluated for its carcinogenic or mutagenic potential, or for impairment of fertility.
Twinrix
21. Hepatitis B Vaccine (Recombinant) RECOMBIVAX HB has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility.
Recombivax HB
22. Hepatitis B Vaccine (Recombinant) ENGERIX-B has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
Engerix-B
23. Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant GARDASIL has not been evaluated for the potential to cause carcinogenicity or genotoxicity. GARDASIL administered to female rats at a dose of 120 mcg total protein, which is equivalent to the recommended human dose, had no effects on mating performance, fertility, or embryonic/fetal survival. The effect of GARDASIL on male fertility has been studied in male rats at an intramuscular dose of 0.5 mL/rat/occasion (120 mcg total protein which is equivalent to the recommended human dose). One group of male rats was administered GARDASIL once, 3 days prior to cohabitation, and a second group of male rats was administered GARDASIL three times, at 6 weeks, 3 weeks, and 3 days prior to cohabitation. There were no treatment-related effects on reproductive performance including fertility, sperm count, and sperm motility. There were no treatment-related gross or histomorphologic and weight changes on the testes.
Gardasil
24. Human Papillomavirus 9-valent Vaccine, Recombinant GARDASIL 9 has not been evaluated for the potential to cause carcinogenicity, genotoxicity or impairment of male fertility. GARDASIL 9 administered to female rats had no effects on fertility [see Pregnancy (8.1)].
Gardasil 9
25. Human Papillomavirus Bivalent (Types 16, 18) Vaccine, Recombinant CERVARIX has not been evaluated for its carcinogenic or mutagenic potential. Vaccination of female rats with CERVARIX, at doses shown to be significantly immunogenic in the rat, had no effect on fertility.
Cervarix
26. Influenza A (H1N1) 2009 Monovalent Vaccine Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor AFLURIA has been evaluated for carcinogenic or mutagenic potential or for impairment of fertility.
No Trade Name
27. Influenza A (H1N1) 2009 Monovalent Vaccine Neither Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal nor FluMist have been evaluated for carcinogenic or mutagenic potential or potential to impair fertility.
No Trade Name
28. Influenza A (H1N1) 2009 Monovalent Vaccine Neither Influenza A (H1N1) 2009 Monovalent Vaccine nor FLULAVAL has been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
No Trade Name
29. Influenza A (H1N1) 2009 Monovalent Vaccine Neither FLUVIRIN nor the Influenza A (H1N1) 2009 Monovalent Vaccine have been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
No Trade Name
30. Influenza A (H1N1) 2009 Monovalent Vaccine Neither Fluzone vaccine nor Influenza A (H1N1) 2009 Monovalent Vaccine have been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
No Trade Name
31. Influenza Virus Vaccine, H5N1 (for National Stockpile) Influenza Virus Vaccine, H5N1, has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
No Trade Name
32. Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted has not been evaluated for carcinogenic or mutagenic potential, or male infertility in animals. Vaccination of female rats with Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted had no effect on fertility [see 385 Pregnancy (8.1)].
No Trade Name
33. Influenza Vaccine, Adjuvanted FLUAD has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. FLUAD did not affect female fertility in a rabbit reproductive and developmental toxicity study.
FLUAD
34. Influenza Vaccine AFLURIA QUADRIVALENT has not been evaluated for carcinogenic or mutagenic potential, or male infertility in animals. A developmental toxicity study conducted in rats vaccinated with AFLURIA (trivalent formulation) revealed no impact on female fertility (see Pregnancy [8.1]).
AFLURIA QUADRIVALENT
35. Influenza Vaccine FLUCELVAX QUADRIVALENT has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. Administration of Flucelvax vaccine (45 mcg HA/dose) did not affect female fertility in a rabbit reproductive and developmental toxicity study.
Flucelvax Quadrivalent
36. Influenza Virus Vaccine (Trivalent, Types A and B) AFLURIA has not been evaluated for carcinogenic or mutagenic potential, or male infertility in animals. A reproductive study of female rats vaccinated with AFLURIA revealed no impairment of fertility (see Pregnancy, 8.1).
Afluria
37. Influenza Virus Vaccine (Trivalent, Types A and B) FLULAVAL has not been evaluated for carcinogenic, mutagenic potential, or male infertility in 15 animals. Vaccination of female rats with FLULAVAL had no effect on fertility [see Use in Specific Populations (8.1)].
FluLaval
FluMist Quadrivalent has not been evaluated for its carcinogenic or mutagenic potential or its potential to impair fertility.
FluMist
39. Influenza Virus Vaccine (Trivalent, Types A and B) FLUARIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
Fluarix
40. Influenza Virus Vaccine (Trivalent, Types A and B) FLUVIRIN® has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
Fluvirin
41. Influenza Virus Vaccine (Trivalent, Types A and B) AGRIFLU has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility.
Agriflu
42. Influenza Virus Vaccine (Trivalent, Types A and B) Fluzone has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility. Fluzone High-Dose has not been evaluated for carcinogenic or mutagenic potential or for impairment of fertility.
Fluzone, Fluzone High-Dose and Fluzone Intradermal
43. Influenza Virus Vaccine (Trivalent, Types A and B) FLUCELVAX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. FLUCELVAX did not affect female fertility in a rabbit reproductive and developmental toxicity study.
Flucelvax
44. Influenza Vaccine (Trivalent) Flublok has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. A developmental toxicity study conducted in rats vaccinated with Flublok revealed no evidence of impaired female fertility (see Pregnancy [8.1]).
Flublok
45. Influenza Vaccine (Quadrivalent) Flublok Quadrivalent has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility in animals. A developmental toxicity study conducted in rats vaccinated with Flublok (trivalent formulation) revealed no evidence of impaired female fertility (see Pregnancy [8.1]).
Flublok Quadrivalent
46. Influenza Vaccine,Live, Intranasal (Quadrivalent, Types A and Types B) FluMist Quadrivalent has not been evaluated for its carcinogenic or mutagenic potential or its potential to impair fertility.
FluMist Quadrivalent
47. Influenza Virus Vaccine (Quadrivalent, Types A and Types B) FLUARIX QUADRIVALENT has not been evaluated for carcinogenic or mutagenic potential or male infertility in animals. Vaccination of female rats with FLUARIX QUADRIVALENT had no effect on fertility [see Use in Specific Populations (8.1)].
Fluarix Quadrivalent
48. Influenza Virus Vaccine (Quadrivalent, Types A and Types B) Fluzone Quadrivalent has not been evaluated for carcinogenic or mutagenic potential. A reproductive study of female rabbits vaccinated with Fluzone Quadrivalent was performed and revealed no evidence of impaired female fertility [see Pregnancy (8.1)]. Fluzone Quadrivalent has not been evaluated for carcinogenic or mutagenic potential. A reproductive study of female rabbits vaccinated with Fluzone Quadrivalent was performed and revealed no evidence of impaired female fertility [see Pregnancy (8.1)]. For: Package Insert – Fluzone Quadrivalent – Southern Hemisphere formulation (PDF - 288KB) Section 13 omitted
Fluzone Quadrivalent
49. Influenza Virus Vaccine (Quadrivalent, Types A and Types B) FLULAVAL QUADRIVALENT has not been evaluated for carcinogenic, mutagenic potential, or male infertility in animals. Vaccination of female rats with FLULAVAL QUADRIVALENT had no effect on fertility [see Use in Specific Populations (8.1)].
FluLaval Quadrivalent
50. Japanese Encephalitis Virus Vaccine, Inactivated, Adsorbed IXIARO has not been evaluated for carcinogenic or mutagenic potential. IXIARO was found to have no effect on fertility of female rats at intramuscular doses of up to 300-fold excess relative to the projected human dose (on a mg/kg basis) administered prior to and after mating [See Use in Specific Populations (8.1)]. The effect of IXIARO on male fertility has not been evaluated.
Ixiaro
51. Japanese Encephalitis Virus Vaccine Inactivated No studies have been performed to evaluate carcinogenicity, mutagenic potential, or impact on fertility.
JE-Vax
52. Measles and Mumps Virus Vaccine, Live M-M-VAX has not been evaluated for carcinogenic or mutagenic potential, or potential to impair fertility.
M-M-Vax
53. Measles, Mumps, and Rubella Virus Vaccine, Live M-M-R II has not been evaluated for carcinogenic or mutagenic potential, or potential to impair fertility.
M-M-R II
54. Measles, Mumps, Rubella and Varicella Virus Vaccine Live ProQuad has not been evaluated for its carcinogenic, mutagenic, or teratogenic potential, or its potential to impair fertility.
ProQuad
55. Meningococcal (Groups A, C, Y, and W-135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine MENVEO has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility.
Menveo
56. Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine MENHIBRIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
MenHibrix
57. Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine Menactra has not been evaluated for carcinogenic or mutagenic potential, or for impairment of male fertility. A developmental animal toxicity study showed that Menactra had no effects on female fertility in mice [see Pregnancy (8.1) ].
Menactra
58. Meningococcal Group B Vaccine BEXSERO has not been evaluated for carcinogenic or mutagenic potential or impairment of male fertility.
BEXSERO
59. Meningococcal Group B Vaccine Trumenba has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility in males.
TRUMENBA
60. Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined Menomune – A/C/Y/W-135 vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.
Menomune-A/C/Y/W-135
61. Plague Vaccine
No trade name
62. Pneumococcal Vaccine, Polyvalent-- Section 13 omitted
Pneumovax 23
63. Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Prevnar® has not been evaluated for any carcinogenic or mutagenic potential, or impairment of fertility.
Prevnar
64. Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein) Prevnar 13 has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility. In a study in rabbits, no vaccine-related effects were found regarding reproductive performance including female fertility [see Use in Specific Populations (8.1)].
Prevnar 13
65. Poliovirus Vaccine Inactivated (Human Diploid Cell) – No link
Poliovax
66. Poliovirus Vaccine Inactivated (Monkey Kidney Cell) CARCINOGENESIS, MUTAGENESIS, IMPAIRMENT OF FERTILITY: Long-term studies in animals to evaluate carcinogenic potential or impairment of fertility have not been conducted.
IPOL
67. Rabies Vaccine (found no information on carcinogenesis, mutagenesis, or impairment of fertility
Imovax
68. Rabies Vaccine Long-term studies with RabAvert have not been conducted to assess the potential for carcinogenesis, mutagenesis, or impairment of fertility.
RabAvert
69. Rabies Vaccine Adsorbed
No Trade Name
70. Rotavirus Vaccine, Live, Oral ROTARIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
ROTARIX
71. Rotavirus Vaccine, Live, Oral, Pentavalent RotaTeq has not been evaluated for its carcinogenic or mutagenic potential or its potential to impair fertility.
RotaTeq
72. Smallpox (Vaccinia) Vaccine, Live Section 13 omitted
ACAM2000
73. Tetanus & Diphtheria Toxoids Adsorbed for Adult Use No studies have been performed with MassBiologics’ Td to evaluate carcinogenicity, mutagenic potential, or impairment of fertility.
No Trade Name
74. Tetanus & Diphtheria Toxoids Adsorbed for Adult Use TENIVAC vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.
TENIVAC
75. Tetanus Toxoid(Discontinued) No studies have been performed to evaluate carcinogenicity, mutagenic potential, or impact on fertility.
No Trade Name
76. Tetanus Toxoid Adsorbed Diphtheria and Tetanus Toxoids Adsorbed has not been evaluated for carcinogenicity, mutagenic potential, or impairment of fertility.
No Trade Name
77. Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed Adacel vaccine has not been evaluated for carcinogenic or mutagenic potential, or impairment of fertility.
Adacel
78. Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed BOOSTRIX has not been evaluated for carcinogenic or mutagenic potential, or for impairment of fertility.
Boostrix
79. Typhoid Vaccine Live Oral Ty21a Long-term studies in animals with Vivotif have not been performed to evaluate carcinogenic potential, mutagenic potential or impairment of fertility.
Vivotif
80. Typhoid Vi Polysaccharide Vaccine Typhim Vi vaccine has not been evaluated for its carcinogenic potential, mutagenic potential or impairment of fertility.
TYPHIM Vi
81. Varicella Virus Vaccine Live| Section 13 is missing! Pregnancy: Do not administer VARIVAX to females who are pregnant; the possible effects of the vaccine on fetal development are unknown. Pregnancy should be avoided for 3 months following vaccination with VARIVAX. (4.4, 8.1, 17) See 17 for PATIENT COUNSELING INFORMATION and
Varivax
82. Yellow Fever Vaccine YF-VAX has not been evaluated for its carcinogenic or mutagenic potential or its effect on fertility.
YF-Vax
ZOSTAVAX has not been evaluated for its carcinogenic or mutagenic potential, or its potential to impair fertility
Zostavax
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